Status:
COMPLETED
A Comparison of Two Different Doses of Maternal B12 Supplementation in Improving Infant B12 Deficiency and Neurodevelopment
Lead Sponsor:
Sitaram Bhartia Institute of Science and Research
Collaborating Sponsors:
Public Health Foundation of India
Paropakar Matenity and Women's Hospital, Kathmandu, Nepal
Conditions:
Vitamin B 12 Deficiency
Eligibility:
FEMALE
18-35 years
Phase:
NA
Brief Summary
Supplementation with Iron and folate have been part of a worldwide strategy targeting anaemia and neural tube defects for many years. However, vitamin B12 deficiency has received much less attention. ...
Eligibility Criteria
Inclusion
- \<12 weeks gestation
- Vegetarian mothers
Exclusion
- Mothers already on B12 supplementation
- Women with multiple gestation, those diagnosed with chronic medical conditions (diabetes mellitus, hypertension, heart disease, neurological disease or thyroid disease), and those who tested positive for hepatitis B, HIV or syphilis (associated with prematurity, IUGR and other neonatal morbidities which could influence neurodevelopment)
- Women who anticipate moving out of the city before/ after delivery
- Women treated for infertility
- Women with known psychological illnesses including depression
Key Trial Info
Start Date :
September 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 25 2022
Estimated Enrollment :
708 Patients enrolled
Trial Details
Trial ID
NCT04083560
Start Date
September 26 2018
End Date
September 25 2022
Last Update
October 26 2022
Active Locations (2)
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1
Sitaram Bhartia Institute of Science and Research
New Delhi, National Capital Territory of Delhi, India, 110016
2
Rajendra Pant
Kathmandu, Nepal